Following on the footsteps of our American colleagues, MedTech Europe would like to offer some thoughts on the issue of transparency and disclosure laws and how certain adaptations could help to frame transparency for a new reality.
Over the last few years, a number of European countries have passed transparency or disclosure (sometimes also called “Sunshine”) laws which require life science industry to track and publicly report certain payments and transfers of value made to Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs) such as hospitals or medical societies.
The objective of such laws is to provide patients with enhanced transparency into the relationships healthcare providers have with life science manufacturers, including medical technology companies (1). The new MedTech Europe Code of Ethical Business Practice upholds the same objective while addressing the fragmentation created by the different national rules. More importantly, the Code goes a step further.
Let us explain: the Code which entered into force this January introduces several important changes to the way the medical technology industry interacts with HCPs. One key aspect is the prohibition for our member companies to directly support HCPs to attend Third Party Organised Educational Conferences (e.g. paying for the registration fee, travel and lodging). Furthermore, the Code introduces transparency requirements for Educational Grants. They key objective is for companies to stop selecting the HCPs who receive financial support to attend such conferences.
This change means that, from 1 January 2018, HCPs’ independent medical education can only be supported via Educational Grants, They will be provided to an independent third-party, such as a hospital or a scientific society, instead of taking the form of direct and unilateral transfers of value to an individual HCP (such as registration fee, travel and lodging costs). Moreover, companies will no longer be involved in the selection of the HCP recipient and all Grants will need to be published on a European-wide online platform (except where there are equivalent or more stringent national rules apply). This will make it easier for patients all over Europe to access the data instead of having to search in dozens of websites.
In this environment, to the extent that you would consider reviewing these disclosure/Sunshine laws, we would welcome rules that are tailored to this new reality, supporting the major ethical change that industry is driving globally.
For the moment, independently of the true costs for companies to comply with such laws, our companies are encountering issues with several national regulations making it operationally very burdensome (but never illegal) to provide Educational Grants.
For example, in France, if a company wishes to provide a Grant to a hospital to enable their staff to attend a Third-Party Organised Educational Event, the company will need to ensure that the Third Party provides them with the names of the HCPs who will benefit from the Grant. This requirement is in contradiction with the reality of Educational Grants, where companies are neither involved in the selection nor should they know the names of the HCPs which will eventually be supported. The rational of this legal obligation to report these names to the relevant professional board for approval, and then also report the full individual sponsorship in the French transparency platform is logical in a system where companies selected and directly sponsor HCPs, but not when such direct support is not allowed. The situation may soon be similar in Belgium.
In contrast, other countries have foreseen the possibility for medtech companies to provide Grants to independent entities. Their regulations clarify that the data reporting would be done by the entity that receives the Grant, selects the HCPs and manages the logistical aspects, without any involvement of the companies. This is currently the case in Portugal, and from where we stand, it is a more logical and safe approach which at the same time provides the desired transparency.
It is for this reason that we would like to invite all stakeholders to start a dialogue on how the environment is changing. It would be a great opportunity to explain why the industry is moving to a more transparent model and why national and regional laws have to be adapted to this new reality. Listening to what HCPs and HCOs are telling us, industry’s support to independent medical education is key for the patients, HCPs and more generally for the healthcare system. Our companies are keen to preserve this status quo. However, the operational difficulties that some of these national laws create for companies may actually compel them to stop providing Educational Grants, in which case there is the question of who will/should pick up the bill for the independent medical education for HCPs?
This blog is part of the GMTCC 2017 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com.
 It’s important to note that such laws do not restrict industry-physician collaboration or interactions, or prohibit payments or transfers of value. These laws aim at ensuring the legitimacy of these interactions which aim at improving medical outcomes, conducting breakthrough research, training them in innovative products and procedures and helping our national healthcare systems excel in so many ways.